Field of the Invention
The present invention is directed to an instrument assembly and method of use and application in the treatment of heart valve malfunction. In more specific terms the instrument assembly is specifically adapted to treat mitral regurgitation by means of a direct entry of the instrument through the atrial wall rather than through the vascular system, in order to apply sufficient tension to a prolapsing leaflet, including the anterior leaflet and/or the posterior leaflet of the mitral valve, in order to overcome mitral regurgitation.
Description of the Related Art
The human heart is a four chambered pump that moves blood efficiently through the vascular system. During normal operation, blood enters the heart through the vena cava and flows into the right atrium. Thereafter, blood flows from the right atrium through the tricuspid valve and into the right ventricle. Upon contraction of the right ventricle, blood is forced through the pulmonic valve and into the lungs for oxygenation. The oxygenated blood returns from the lungs and enters the heart through the left atrium and passes through the mitral valve into the left ventricle. Upon contraction of the left ventricle the blood therein flows through the aortic valve and into the aorta and throughout the vascular system.
The mitral valve is disposed in flow regulating communication between the left atrium and the left ventricle. It is composed of two valve leaflets, the mitral valve annulus, which forms a ring that supports the valve leaflets; papillary muscles, which tether the valve leaflets to the left ventricle wall, by preventing them from prolapsing back into the left atrium. Chordae tendineae serve to connect the mitral valve leaflets to the papillary muscles thereby further preventing the leaflets from prolapsing back into the left atrium. A dysfunction of any of these components of the mitral valve can cause “mitral regurgitation”. Mitral regurgitation is a disorder of the heart in which the mitral valve does not close properly when the heart pumps out blood. This results in abnormal leaking of blood from the left ventricle back into the left atrium, through the mitral valve, when the left ventricle contracts and is a condition known as “mitral regurgitation”. It is generally recognized in the medical profession that mitral regurgitation is the second most common form of valvular heart disease.
As generally set forth above, when properly functioning, the anterior and posterior valve leaflets of the mitral valve overlap during contraction of the left ventricle and prevent blood from flowing back into the left atrium. This overlap of the 2 leaflets leaning upon each other is called the coaptation and absorbs most of the strain on the mitral apparatus during the ventricular contraction. However, when the mitral valve malfunctions, due to various cardiac diseases, the leaflets are no longer coapting resulting in the mitral valve remaining partially open during ventricular contraction. In turn this allows the “regurgitation” of the blood back into the left atrium, as generally set forth above. When the mitral valve does not close hermetically during the ventricular contraction, the aforementioned back flow of blood to the atrium and the pulmonary vasculature, results in a deleterious condition. More specifically, this condition increases the work load to the heart and may lead to heart failure.
Methods of treating conditions relating to the malfunctioning of the heart valve specifically including valve incompetencies, mitral valve leakage and other heart failure conditions may be in various stages of development, such as the extending of an elongate member transverse across a corresponding or affected heart chamber. Each end of the elongate member extends through a wall of the heart such as the septum wall and an oppositely disposed wall portion, wherein first and second anchoring members are connected to corresponding ends of the elongate member but are disposed external of the heart chamber. Connecting clips or the like are applied to the corresponding exterior ends of the elongate member, resulting in the papillary muscles within the chamber to be effectively re-shaped or repositioned. A predetermined force is applied to the heart itself and/or the affected portions of the heart chamber.
Other specific treatments associated with mitral regurgitation sometimes may include the surgical repair or replacement of the mitral valve, resulting in traumatic and frequently dangerous surgical procedures being performed on a patient.
Accordingly, there is a need in the medical arts for appropriate instrumentation and attendant methods of overcoming heart valve malfunctions, specifically including mitral regurgitation.